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Periodontitis Stage IIINCT06871540

Evaluation Of The Effect Of Streptococcus Salivarius K12 Probiotic In The Treatment Of Periodontitis

A study testing Probiotic Agent and Non-Surgical Intervention in people with Periodontitis Stage III and Probiotic, run by AYŞENUR ŞAHİN at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aims: The use of oral probiotics as an adjunct to the treatment of periodontal diseases is known to be beneficial in antagonizing pathogenic microflora and regulating the host immune response. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis Stage III, Probiotic
What is being tested?
Probiotic Agent and Non-Surgical Intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2023to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female aged 18-60 years,
  • No systemic disease,
  • No periodontal treatment in the last 6 months,
  • No antibiotic therapy in the last 6 months,
  • Diagnosed with stage 3 periodontitis according to the 2017 periodontal disease classification

Who cannot join

  • Periodontal treatment within sixteen months,
  • Smoking,
  • Patients with systemic health problems such as diabetes, rheumatoid arthritis, neurological diseases, lung and kidney diseases,
  • Pregnancy or lactation,
  • Acute oral lesions or necrotizing ulcerative periodontitis.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • İnönü Üniversitesi Diş Hekimliği Fakültesi

    Malatya, Battalgazi

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation Of The Effect Of Streptococcus Salivarius K12 Probiotic In The Treatment Of Periodontitis: A Randomized Controlled Clinical Trial

Aims: The use of oral probiotics as an adjunct to the treatment of periodontal diseases is known to be beneficial in antagonizing pathogenic microflora and regulating the host immune response. The aim of this clinical study was to evaluate the clinical, microbiologic and biochemical effect of Streptococcus salivarius (S. salivarius) K12 probiotic tablet as an adjunct to scaling and root planing (SRP) treatment in stage 3 periodontitis patients.

Methods: The study included 30 systemically healthy stage 3 periodontitis patients. After non-surgical periodontal treatment, participants were randomly assigned to the test (SRP+Probiotic, n=15) or control (SRP, n=15) group. Patients in the test group used probiotic tablets once daily for 30 days. Clinical (Plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)), microbiological (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum) and biochemical (IL-6, IL-8, IL-10) measurements were performed at baseline (before SRP), 30. and 90th days. Data were analyzed statistically.

Keywords: Microbiology, Periodontitis, Probiotics, Cytokines

Being tested
Probiotic Agent, Non-Surgical Intervention
Keywords
Microbiology, Periodontitis, Probiotics, Cytokines
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic AgentOther

    Patients in the test group were instructed to take one tablet immediately after tooth brushing (before bedtime) once daily for 30 consecutive days. Probiotic was administered in tablets containing 1x109 cfu/g S. salivarius K12.

  • Non-Surgical InterventionOther

    Patients in the control group received non-surgical periodontal treatment only.

Study groups in NCT06871540
Study groupRoleWhat they receive
Test GrubuActive comparatorNot described
Receives: Other: Probiotic Agent; Other: Non-Surgical Intervention
ControlOtherNot described
Receives: Other: Non-Surgical Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Porphyromonas gingivalis at 3 months

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start1 Oct 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06871540
Sponsor's protocol ID
INU-DHF-AS-01
Status last verified
Mar 2025
First submitted
6 Mar 2025
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haffajee AD, Cugini MA, Dibart S, Smith C, Kent RL Jr, Socransky SS. Clinical and microbiological features of subjects with adult periodontitis who responded poorly to scaling and root planing. J Clin Periodontol. 1997 Oct;24(10):767-76. doi: 10.1111/j.1600-051x.1997.tb00195.x.

    PubMed 9350562

  • Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

    PubMed 29926951

  • Servin AL, Coconnier MH. Adhesion of probiotic strains to the intestinal mucosa and interaction with pathogens. Best Pract Res Clin Gastroenterol. 2003 Oct;17(5):741-54. doi: 10.1016/s1521-6918(03)00052-0.

    PubMed 14507585

  • Morales A, Carvajal P, Silva N, Hernandez M, Godoy C, Rodriguez G, Cabello R, Garcia-Sesnich J, Hoare A, Diaz PI, Gamonal J. Clinical Effects of Lactobacillus rhamnosus in Non-Surgical Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Trial With 1-Year Follow-Up. J Periodontol. 2016 Aug;87(8):944-52. doi: 10.1902/jop.2016.150665. Epub 2016 Mar 4.

    PubMed 26944407

  • Darveau RP, Hajishengallis G, Curtis MA. Porphyromonas gingivalis as a potential community activist for disease. J Dent Res. 2012 Sep;91(9):816-20. doi: 10.1177/0022034512453589. Epub 2012 Jul 6.

    PubMed 22772362

  • Stamatova I, Meurman JH. Probiotics and periodontal disease. Periodontol 2000. 2009;51:141-51. doi: 10.1111/j.1600-0757.2009.00305.x. No abstract available.

    PubMed 19878473

  • Alanzi A, Honkala S, Honkala E, Varghese A, Tolvanen M, Soderling E. Effect of Lactobacillus rhamnosus and Bifidobacterium lactis on gingival health, dental plaque, and periodontopathogens in adolescents: a randomised placebo-controlled clinical trial. Benef Microbes. 2018 Jun 15;9(4):593-602. doi: 10.3920/BM2017.0139. Epub 2018 Apr 10.

    PubMed 29633646

  • Twetman S, Derawi B, Keller M, Ekstrand K, Yucel-Lindberg T, Stecksen-Blicks C. Short-term effect of chewing gums containing probiotic Lactobacillus reuteri on the levels of inflammatory mediators in gingival crevicular fluid. Acta Odontol Scand. 2009;67(1):19-24. doi: 10.1080/00016350802516170.

    PubMed 18985460

  • Rossi V, Romagna R, Angst PDM, Gomes SC. Gingival crevicular fluid response to protocols of non-surgical periodontal therapy: A longitudinal evaluation. Indian J Dent Res. 2019 Sep-Oct;30(5):736-741. doi: 10.4103/ijdr.IJDR_148_16.

    PubMed 31854365

  • Kowashi Y, Jaccard F, Cimasoni G. Sulcular polymorphonuclear leucocytes and gingival exudate during experimental gingivitis in man. J Periodontal Res. 1980 Mar;15(2):151-8. doi: 10.1111/j.1600-0765.1980.tb00269.x. No abstract available.

    PubMed 6445977

  • Ince G, Gursoy H, Ipci SD, Cakar G, Emekli-Alturfan E, Yilmaz S. Clinical and Biochemical Evaluation of Lozenges Containing Lactobacillus reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Chronic Periodontitis. J Periodontol. 2015 Jun;86(6):746-54. doi: 10.1902/jop.2015.140612. Epub 2015 Mar 5.

    PubMed 25741580

  • Laleman I, Yilmaz E, Ozcelik O, Haytac C, Pauwels M, Herrero ER, Slomka V, Quirynen M, Alkaya B, Teughels W. The effect of a streptococci containing probiotic in periodontal therapy: a randomized controlled trial. J Clin Periodontol. 2015 Nov;42(11):1032-41. doi: 10.1111/jcpe.12464. Epub 2015 Nov 29.

    PubMed 26427036

  • Tekce M, Ince G, Gursoy H, Dirikan Ipci S, Cakar G, Kadir T, Yilmaz S. Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study. J Clin Periodontol. 2015 Apr;42(4):363-72. doi: 10.1111/jcpe.12387. Epub 2015 Apr 10.

    PubMed 25728888

  • Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol. 2013 Nov;40(11):1025-35. doi: 10.1111/jcpe.12155. Epub 2013 Sep 15.

    PubMed 24164569

  • Vivekananda MR, Vandana KL, Bhat KG. Effect of the probiotic Lactobacilli reuteri (Prodentis) in the management of periodontal disease: a preliminary randomized clinical trial. J Oral Microbiol. 2010 Nov 2;2. doi: 10.3402/jom.v2i0.5344.

    PubMed 21523225

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic Agent and Non-Surgical Intervention in people with Periodontitis Stage III and Probiotic, run by AYŞENUR ŞAHİN at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Porphyromonas gingivalis at 3 months (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06871540, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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